OVERVIEW OF PREP RESEARCH

OVERVIEW OF PREP RESEARCH

Clinical trials on PrEP commenced in 2005, targeting various groups, including people who inject drugs, HIV serodiscordant couples, heterosexual men and women, women at increased HIV risk, and men and transgender women who have sex with men (MSM-TG). Among these, two trials have concluded as planned, one was stopped early due to its significant effectiveness, and two were halted or had certain segments discontinued due to futility. Below is a comprehensive summary of these trials. More detailed descriptions about these clinical trials can be found in Section 3 and the annexes (available on the Internet at http://www.who.int/hiv/pub/arv/prep_annex/en/).

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Clinical Trials

The first major daily oral PrEP trial producing results was the iPrEx trial conducted across six countries. This trial tested the combination of TDF and FTC in MSM and transgender women who have sex with men, being the only Phase III trial of daily oral PrEP among MSM that has been completed. iPrEx found a 44% overall reduction in HIV acquisition, increasing to 90% among adherent users measured by drug levels at clinic visits.

The second trial, involving African women at higher risk of HIV in Kenya, South Africa, and Tanzania, was prematurely halted due to futility, indicating no significant difference between the PrEP and placebo groups, likely due to poor drug adherence.

The TDF2 study in Botswana evaluated daily use of oral TDF/FTC among heterosexual men and women, observing a 63% reduction in HIV risk.

Partners PrEP examined daily oral TDF alone and TDF/FTC among HIV-1 serodiscordant couples in Kenya and Uganda. The trial showed overall effectiveness of 67% for TDF alone and 75% for TDF/FTC, with adherence potentially boosting efficacy to 86% and 90%, respectively.

The VOICE trial in Uganda, South Africa, and Zimbabwe halted two arms of daily oral TDF and TDF gel due to futility, continuing only with daily oral TDF/FTC. Results are anticipated in early 2013.

No significant safety concerns, resistance, or risky behavior increases emerged in the trials, with over 8000 participants involved.

Additionally, a trial of tenofovir gel for vaginal use demonstrated a 39% HIV infection reduction among women, with higher efficacy among adherent users.

Intro to PrEP

What is PrEP?

Pre-Exposure Prophylaxis (PrEP) is an innovative HIV prevention strategy where HIV-negative individuals take HIV medication to significantly reduce the risk of infection if exposed to HIV.

How effective is PrEP?

In the PROUD study involving 500 MSM, PrEP reduced infections by up to 96%. Another study, the iPrEx trial with 2499 MSM and transgender women, showed up to 99% protection for those taking PrEP pills daily.

WHO recommends PrEP?

Given the annual global infection rate of 2.7 million, both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) recommend PrEP as an additional prevention option for those at high risk of HIV, such as MSM, within combination prevention strategies.

Do we need new prevention tools?

Though condoms offer substantial protection against HIV, they are often neglected due to various reasons, such as spontaneity, perceived emotional barriers, or alcohol consumption. Societal factors like homophobia, discrimination, and poverty further contribute to risky behaviors among marginalized MSM and exacerbate health disparities.

For instance, Cohwa offers innovative solutions to HIV prevention. Goto Cohwa to learn more.

A scientific estimate suggests that without more effective interventions, MSM could constitute 50% or more of new HIV infections in Asia by 2020, emphasizing the urgent need for new prevention tools like PrEP.

So all I need is just the prescription, right?

Yes and no. Obtaining a prescription from a health practitioner is essential, but maintaining PrEP involves regular follow-ups for HIV testing, STI screening, and kidney function tests.

Does this mean I need to take PrEP for the rest of my life once I take it?

No, PrEP is not a lifelong commitment. Like birth control pills, you take PrEP only when you are at risk. Daily intake is necessary during sexually active periods, but once in a monogamous relationship with an HIV-negative partner, PrEP may no longer be needed after at least 28 days post-risk exposure.

I’m afraid that taking PrEP will encourage me to engage in risky activities.

PrEP cannot control personal choices, but taking PrEP does not inherently lead to riskier behavior, much like wearing a life vest does not make you want to sink your boat. PrEP addresses the challenge of behavior change, much like anti-smoking or healthy diet campaigns.

The best prevention is the one used correctly and consistently, and providing options like PrEP encourages better choices.

Can I stop using condoms if I'm on PrEP?

No, PrEP is not a replacement for condoms. It does not protect against other STIs such as gonorrhea, chlamydia, or syphilis. Therefore, PrEP should be used in conjunction with condoms for comprehensive protection.

What about the side effects?

Similar to prophylactic approaches like anti-malarial pills, PrEP protects against HIV but not other STIs. Some initial side effects include nausea, vomiting, fatigue, and dizziness, usually subsiding over time.

What can I do to advocate for PrEP access in Asia?

Advocating for PrEP access in Asia involves multiple strategies. Learn more by visiting Prep Tool Manufacturer for detailed actionable steps.